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FDAFDA · Food and drugs·Recall number Z-2565-2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

Published August 21, 2024 · Recall initiated: June 11, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Merit Medical Systems, Inc.
Distributor
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Lot
Catalog Number/UDI-DI code/Lot Numbers: K10-01722QP 00884450570340 H2410331 H2471342 H2480639 H2502357 H2513044 H2525139 H2543652 H2558245 H2564522 H2825008 H2831600 H2875331 H2915643 K10-03220AP 00884450174036 H2406448 H2408885 H2423250 H2428461 H2448942 H2500653 H2536816 H2567302 H2601107 H2623288 H2659637 H2665379 H2708979 H2721135 H2730471 H2760266 H2774855 H2794124 H2812819 H2829027 H2838364 H2843344 H2850151 H2868190 H2872165 H2905227 H2913401 K10-03591KP 00884450380635 H2391366 H2408970 H2441713 H2472906 H2482293 H2491990 H2496930 H2500665 H2518450 H2527822 H2551825 H2567305 H2627298 H2638378 H2645033 H2708977 H2716700 H2730479 H2751466 H2778878 H2784096 H2794135 H2808194 H2821498 H2918877 K10-04291AP 00884450176320 H2352552 H2401233 H2418439 H2431501 H2461658 H2475592 H2492022 H2511077 H2513895 H2518283 H2530047 H2538940 H2551884 H2563710 H2567356 H2641969 H2662164 H2679955 H2713607 H2728230 H2744412 H2785947 H2795948 H2809437 H2818171 H2832163 H2843600 H2866062 H2896827 H2912839 H2918929 K10-04386CP 00884450197523 H2384157 H2401236 H2423252 H2444355 H2470464 H2496947 H2522107 H2559517 H2573434 H2655272 H2659665 H2665397 H2708975 H2730487 H2744361 H2746709 H2755852 H2778887 H2834781 H2838372 H2844785 H2872168 H2882630 H2897046 H2913305 H2918921 K10-04429 00884450176795 H2418279 H2448704 H2468945 H2489657 H2505650 H2518225 H2585617 H2600807 H2642069 H2642462 H2665625 H2692001 H2703157 H2728629 H2735292 H2756121 H2776259 H2795556 H2814363 H2832784 H2845927 H2875164 H2913298 H2928657 K10-04479P 00884450177075 H2409371 H2475562 K10-04722C 00884450270431 H2429014 H2496323 H2520764 H2557465 H2589898 H2626879 H2666564 H2736535 H2777762 H2799974 H2828177 H2859884 H2864805 H2905908 K10-04931B 00884450393147 H2402920 H2469836 H2474257 H2476022 H2480793 H2494885 H2751615 H2782208 H2787882 H2800804 H2815006 H2824607 H2871355 K10-05043A 00884450202074 H2610631 H2627090 H2680755 H2728653 H2875168 H2928687 K10-05120P 00884450197202 H2399127 H2431312 H2498451 H2523383 H2527704 H2553771 H2576585 H2655265 H2669130 H2720156 H2757798 H2831587 H2837463 H2847025 H2867088 H2890107 H2915648 H2920730 K10-05222 00884450230824 H2839171 H2849535 K10-05251AP 00884450265499 H2408968 H2428471 H2448946 H2469092 H2475567 H2562411 H2567311 H2585822 H2627308 H2633766 H2655299 H2665378 H2675063 H2708968 H2744380 H2755857 H2774890 H2784101 H2789811 H2802599 H2829053 H2843351 H2877200 H2891663 H2928416 K10-05530 00884450284407 H2581869 K10-06011AP 00884450634516 H2752358 H2771050 H2818172 H2849571 H2866057 K10-06012P 00884450681107 H2464776 H2507506 H2507672 H2518503 H2576565 H2585848 H2641118 H2650735 H2707287 H2763420 H2900287 H2915472 K10-06033AP 00884450663707 H2780818 H2804119 H2816921 H2831647 H2837566 H2867095 H2890128 H2910148 K10-06066 00884450695524 H2744543 H2824018 H2869593 H2884336 H2912589 K10-06086P 00884450695111 H2804075 H2813661 H2831607 H2867102 K10T-05227 00884450619957 T2736090 T2842237 T2862543 T2899709 K10T-05815 00884450486061 T2143908 T2310781 T2323193 T2330789 T2340443 T2363413 T2363416 T2414967 T2427552 T2437298 T2474307 T2534990 T2534991 T2576721 T2580922S K10T-05816 00884450486115 T2198303 T2237161 T2238504 T2259632 T2259636 T2259646 T2323194 T2330794 T2330795 T2330796 T2363411 T2363412 T2363417 T2370536 T2399814 T2417139 T2427554 T2427562 T2456678 T2469555 T2474316 T2474987 T2474987S T2534987 T2534988 T2542105 T2553454 T2553455 T2553457 T2580725S T2590403 T2626099 K10-00592K 00884450235140 H2393452 H2420172 H2443412 H2451992 H2470701 H2476538 H2521149 H2521296 H2544998 H2577007 H2613404 H2642940 H2697212 H2707453 H2744182 H2763384 H2792508 H2846785 H2850808 H2864775 H2911026 K10-00777BP 00884450171356 H2382837 H2412350 H2412351 H2439664 H2454880 H2469915 H2496127 H2521359 H2532904 H2549693 H2564318 H2608724 H2630383 H2671723 H2676769 H2681498 H2729338 H2744246 H2782393 H2796088 H2800051 H2823930 H2828210 H2900295 H2908480 H2928030 K10-00785LP 00884450171363 H2354646 H2359
Risk classification
Class II
Area (FDA)
device
Country
United States

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